The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-0438-2023·Announced 2022-12-21

Arrow AC3 Optimus IABP recalled for shortened battery run-times

Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall, which per the severity rubric indicates a device malfunction that could result in serious adverse health consequences or death. An intra-aortic balloon pump is a life-critical cardiac support device; shortened battery run-times pose direct risk to device function during patient use.

Plain-English summary

The Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP), model IAP-0700, has been recalled due to a potential issue with shortened battery run-times. The recall affects all lot and serial numbers of this device and applies to worldwide distribution.

Device identification codes include UDI/DI (01) 0 0801902 08496 5 and (01) 0 0801902 08496 6. The U.S. Food and Drug Administration classified this as a Class I recall, which indicates device failure could result in serious adverse health consequences or death. Arrow International Inc. is responsible for initiating this recall.

Intra-aortic balloon pumps are cardiac support devices used in hospital settings to assist patients with critical heart function. Shortened battery run-times could compromise the device's ability to function during patient care. Healthcare facilities and medical professionals using this equipment should be informed of this recall.

The recalled product

Product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Manufacturer
ARROW INTERNATIONAL Inc.
Category
Medical Device — Cardiac Support Device
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI (01) 0 0801902 08496 5
  • (01) 0 0801902 08496 6
  • All Lot/Serial Numbers

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 31 recalled by ARROW INTERNATIONAL Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 31 products in this recall →

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